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510(k) Data Aggregation
K Number
K192259Device Name
Philips IntelliSite Pathology Solution
Manufacturer
Philips Electronics Nederland B.V.
Date Cleared
2019-09-20
(30 days)
Product Code
PSY
Regulation Number
864.3700Why did this record match?
Applicant Name (Manufacturer) :
Philips Electronics Nederland B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS.
Device Description
Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. PIPS consists of two sub-systems and a display component:
- . Image Management System (IMS)
- Ultra Fast Scanner (UFS)
- . Display
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K Number
K171055Device Name
Philips BlueControl
Manufacturer
Philips Electronics Nederland B.V.
Date Cleared
2017-07-06
(87 days)
Product Code
ONE
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Philips Electronics Nederland B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips BlueControl is intended to emit energy in the blue region of the spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat mild psoriasis vulgaris.
Device Description
The Philips BlueControl is a rechargeable battery-operated, wearable device for delivery of blue light to treat mild psoriasis vulgaris. It is a prescription device designed for home use. The Philips BlueControl is sold as a kit, which contains the following items: Components: o BlueControl Device o Fixation Strap (Device Holder and Slings) o Power Supply (USB Cable, Adapter and Charger) Accessory: ● 0 Carrying Case Instructions for Use.
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